FDA deadline extended on HGS/GSK lupus drug

Human Genome Sciences and partner GlaxoSmithKline will have to wait a bit longer before finding out if their eagerly-anticipated lupus drug Benlysta is to be approved in the USA.

The US Food and Drug Administration has extended the Prescription Drug User Fee Act target date for its priority review of Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus from December 9 to March 10, 2011. The delay comes almost three weeks after the agency's Arthritis Advisory Committee voted 13 to 2 to recommend approval, and 10-5 that there was substantial evidence Benlysta was effective in relieving pain and flares-up caused by lupus. They voted 14 to 1 that it was safe, despite a slight rise in deaths and suicides among those on the drug compared to placebo.

All this paved the way for Benlysta to be the first new drug to be approved for lupus in more than half a century. However at that meeting, HGS notes that the FDA "requested some additional information", without specificying what exactly, and that "has been submitted".

HGS shares slipped on the news but analysts do not believe that the deadline extension is a serious problem. If approved, forecasts hover around the $5 billion a year mark, in terms of peak sales.

GSK eyes China purchaseMeantime, it is being reported that GSK is poised to acquire China's Nanjing MeiRui Pharma as part of its expansion into the emerging markets.

The price tag being bandied around is about $100 million. Nanjing MeiRui specialises in urological conditions, specifically overactive bladder and benign prostatic hyperplasia.